TerminatedNot Applicable

Colombia Epidemiologic Surveillance Study

Stopped: See termination reason in detailed description.

Brazil, Colombia, Costa Rica32,867 participantsStarted 2006-09

Plain-language summary

The study will determine the reduction in invasive pneumococcal disease (IPD) after the introduction of a National Immunization Program with PCV-7 in Bogota. The original LEAP study determine incidence of IPD prior to introduction of PCV-7 in Brazil, Costa Rica and Colombia. LEAP II is the continuation of the study in Colombia only.

Who can participate

Age range28 Days – 36 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children 28 days to 36 months of age * Presenting to a participating facility with a measured temperature of 39 degrees C or higher within 24 hours prior to screening, or with clinical suspicion of pneumonia, meningitis, bacteremia, sepsis, or other invasive pneumococcal disease Exclusion Criteria: * Any patient hat based on the clinical impression of the treating physician should not participate in the study: examples such as those with suspected dengue or urinary tract infection

What they're measuring

Annual age specific incidence rate of invasive pneumococcal disease based on the number of identified cases from the study sites and the size of the population at risk for children 28 days to 36 months of age

Timeframe: 2 years

Trial details

NCT IDNCT00428051

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2011-02

View on ClinicalTrials.gov More Pneumonia trials